[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Notices]
[Pages 5223-5224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00939]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-new]


Agency Information Collection Request. 30-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995, the Office of the Secretary (OS), Department of Health and 
Human Services, is publishing the following summary of a proposed 
collection for public comment.

DATES: Comments on the ICR must be received on or before February 18, 
2021.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected] 
or (202) 795-7714. When submitting comments or requesting information, 
please include the document identifier 0990-New-30D and project title 
for reference.

SUPPLEMENTARY INFORMATION: Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.
    Title of the Collection: Incident Report Form.
    Type of Collection: New.
    OMB No. 0990-NEW--Office of the Assistant Secretary for Health, 
Office for Human Research Protections.
    Abstract: The Office of the Assistant Secretary for Health, Office 
for Human Research Protections is requesting approval for three years 
of a new information collection on the OHRP Incident Report Form. This 
form will facilitate prompt reporting of specific human subject 
protection incidents to OHRP by organizations and institutions 
conducting or reviewing human subjects research, and will provide a 
simplified standardized format for the reports. The information 
collected on the form will help OHRP to ensure the safety of human 
research subjects involved in non-exempt HHS-conducted or -supported 
research and to ensure that the research is conducted in accordance 
with the HHS Protection of Human Subjects regulations at 45 CFR part 
46.
    Likely Respondents: Institutions or organizations conducting non-
exempt HHS-conducted or -supported human subjects research.

[[Page 5224]]



                                          Annualized Burden Hour Table
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                                                   Responses per     Number of       Hours per     Total burden
              Forms                 Respondents     respondent       responses       response          hours
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Incident Report Form............             500               1             500             0.5             250
Incident Report Form............             200               2             400             0.5             200
Incident Report Form............             100               3             300             0.5             150
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    Total.......................  ..............  ..............  ..............  ..............             600
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    Dated: January 12, 2021.
Sherrette A. Funn,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
[FR Doc. 2021-00939 Filed 1-15-21; 8:45 am]
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